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MTSparky - an important point and often overlooked

Crumbs,

Re. Daily Mail article, read quite a few comments yesterday from US commentators along similar lines and the issue seems to be simply that the US regulators have yet to finish their review but the halt has today been lifted in India so hopefully it's just a matter of time.

Worth noting that the AZN trial was also halted back in July for very similar reasons and it transpired that the patient in question had developed Multiple Sclerosis and her symptoms were completely unrelated to the vaccine. As I understand it, the circumstances around the adverse events in the latest halt have been fully investigated by the UK regulators (MHRA) and they have confirmed that it is safe to continue with the study. That only happened on Saturday and I assume their findings will be disseminated to the US regulators.

On a broader note, Trump's comments regarding the Oxford vaccine seem to have resulted in the whole thing being politicised which is such a shame. The publicity surrounding this halt has the potential to be damaging to the whole field and make recruitment for all vaccine trials just that little harder. Indeed other developers have already had patients withdraw from their clinical trials due to concerns about the possibility of adverse events. It's for precisely this reason, halts in clinical trials to investigate SAE's (which happen all the time) aren't usually reported by the media until they've been investigated and it's known whether or not they really are drug related.

Typical of Daily Mail to stoke the fires and add to the scaremongering but it plays right into the hands of the antivax brigade.

billbrown -

Yep, ADC field is hotting up. Mindful of Scancell's Avidimab statement in the funding circular, I do wonder whether the first commercial deal for glycan mAbs might be a collaboration to evaluate FG88 (or another) as an ADC with an upfront payment and option to license at the end.

Ciaskin,

The aim of the fund is to generate an income for its investors and they will have taken profit to contribute to their next dividend payment. Worth noting that they had previously sold just under £700k of ODX stock to fund their August dividend.

I believe the fund now has a strategy to move away from early stage, non-revenue stocks and invest purely in revenue generating, larger concerns so as and when the opportunity arises we may see further profit taking from Hygea.

ciaskin,

This is why, from their announcement this morning:-

'generating a profit versus original cost of £63,110 (a 2x return on the original investment'

https://www.londonstockexchange.com/news-article/HYG/investment-realisations-and-nav/14687131

Yep realistic best case scenario but only my opinion and much will obviously depend on Amryt's CRO, their data management team and the FDA.

Re. the CLN's , yes of course they can be converted to stock at any time Redmile/Vulpes choose - from memory they just have to give 10 days notice.

To answer Botski's question though, it's likely that the terms and conditions of the loan prevent Scancell from repaying it early. Worth remembering that these CLNs are interest free and Redmile/Vulpes will be looking to see a return on their investment.

Propinquity,

It'll take many weeks to compile and analyse the mountains of data from the AP101 trial and to complete the NDA/MA for submission to the FDA/EMA. Amryt have stated that they expect applications to be filed to both regulators by the end of Q1 2021.

AP101 has FDA fast track designation and one of the benefits is the ability to do rolling submissions of NDA's. Completion of a New Drug Application is a mammoth task and it's hard to overstate the amount of work involved. Every aspect of the drug has to be covered including the exact composition of the drug, how it's manufactured, patents, data from preclinical research in mice, through all stages of clinical trials etc. etc. Rolling review allows companies to submit whole sections of the NDA to the FDA as and when they're completed rather than waiting until the whole NDA is complete. It looks like Amryt will be taking advantage of this benefit, nevertheless it's still likely to take around 6 months for a decision and that's if all goes smoothly.

Yes, good news and good to see progress with AP103.

Worth noting that when it comes to applying to the FDA for Orphan Drug Designation, one of the benefits is the waiver of PDUFA user fees which must be paid when applying for new drug approval. Of course there's a long, long way to go before AP103 gets to that stage but it's a saving of a significant amount of money. The current fee is $2,942,965.

This may well already have been posted but good to see the EB patient advocacy group, debra covering the EASE phase III trial results

https://www.debra.org.uk/news/debra-news/post/262-amryt-pharma-announces-positive-top-line-results-from-pivotal-phase-3-aeasea-trial-of-wound-healing-gel-in-epidermolysis-bullosa

Inanaco,

ADC field is certainly heating up - all about avoiding off target toxicity. So any mAbs that bind strongly to targets with very, very low expression on healthy cells would be of interest for use as an ADC. We know from recent RNSs that Scancell's glycan mAbs have been undergoing evaluation as an ADC - wonder whether this may be the subject of the first deal? Time will tell I guess.

By the way, first day of ESMO today and assume Merck deal was timed to coincide.

Yes, of course this is research that has been paid for by Redx and I guess everyone has to decide for themselves what it says (if anything) about Redmile's intentions.

The idea behind Trinity Delta's research is to fill the gap left by the lack of independent analyst coverage for these early stage bios and it's aimed at retail investors.

Trinity Delta have issued their first note on Redx Pharma - link below.

https://www.trinitydelta.org/companies/redx-pharma/

https://www.trinitydelta.org/research-notes/proof-is-in-the-pipeline/

Some really interesting research using Parsortix from the University of Basel has just been published.

They describe how CTC clusters have an 'extraordinary ability to initiate metastasis' and looking at breast cancer cells tried to find what triggers the primary tumour to start shedding these clusters. They found that whilst single CTCs have normal oxygen levels, clusters are being starved of oxygen.

They found that VEGF inhibitor drugs such as bevacizumab (Avastin) which reduce oxygen levels within the tumour, shrink the primary tumour but lead to a higher rate of shedding of CTC clusters. However, pro-angiogenic treatments allow the primary tumour to grow but prevent the shedding of CTC clusters and therefore suppress metastasis.

Amazing stuff really and a perfect example of how liquid biopsies are leading to greater understanding of exactly how cancer spreads. Worth noting this research wouldn't have been possible with a ctDNA system.

https://www.sciencedirect.com/science/article/pii/S2211124720310949#!

From Scancell's point of view, perhaps one of the most interesting points about the Immunomedics takeover is Redmile's involvement.

Their 13f SEC filing of 14th August tells us that Redmile bought 3.49 BILLION! shares in Immunomedics at some point during Q2 this year. According to their March filing they held no IMMU stock but by the end of June they had acquired 3,489,900 shares. The purchase price could have been anywhere between $9 and $36 - if you look at IMMU's share chart you can have a guess as to when they bought and roughly what they paid. So here we are just a few months later and they'll be getting $88 per share in cash.

So a fantastic result for Redmile and a perfect example of their investment strategy in action, ie. to look for fundamental changes in the outlook for a company. In their own words, 'The Firm seeks to recognize product cycles and investment themes before they become the focus of mainstream investors'

Whilst we're on the subject, I notice Redx picked up another deal last week - their second since Redmile's investment.

GF123

Don't you mean when?

GF123

No, I know you didn't and I was replying to Inanaco's post but you've just made exactly the point I've been trying to make.

Your investment strategy has been right for you, for your own personal circumstances and you're comfortable with it. Does it make you smarter than those buying in now or those who have traded Scancell? No, of course it doesn't. Could you have made more money with a different strategy? Very possibly.

GF123 - but it's not a question of buying in at a better price than others with large holdings - the price of your large holding is irrelevant to mine. You may well have a lower average but you have also had a large amount of capital tied up that could have been providing you with returns elsewhere.

Just a few weeks ago, I could have taken part in the placing at 5.5m - for the following 3 weeks I could have bought in the 6p range, sometimes at volume. I didn't but plenty did and good on them, they've called it right IMO.

The point I'm really trying to make of course is that everybody has their own investment strategy based on their own personal circumstances. To claim that those who have sat on large investments here with a declining SP for 8 years somehow have superior investment skills and have now been proven right is odd IMO.

GF123,

Thanks for correcting me and I would point out that I'm also a long term holder - very long term. I may be being a little simple here but I have a feeling that if I had sold my entire Scancell holding 8 years ago at 50p or even at 30p just 5 years ago and reinvested elsewhere and then bought back at 5.5p or 6p or then surely I'd be better off than I am today - no?

GF123,

I have no idea how many shares you have, it's none of my business.